Release Date: 25-Jan-2025
SHR-A2009 is an antibody-drug conjugate (ADC) developed by Suzhou Suncadia Biopharmaceuticals, a subsidiary of Jiangsu HengRui Medicine, a Chinese biopharmaceutical firm. It features a human IgG1 monoclonal antibody that targets the human epidermal growth factor receptor 3 (HER3), conjugated via a cleavable peptide linker to a cytotoxic DNA topoisomerase I inhibitor. Upon administration, the anti-HER3 antibody binds to tumor cells expressing HER3, resulting in the internalization of the ADC. The linker is cleaved within the tumor cell, releasing the topoisomerase I inhibitor, which binds to DNA topoisomerase I, leading to DNA breaks, inhibiting DNA replication, and inducing apoptosis in tumor cells.
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SHR-A2009 is presently in Phase 2 clinical trials in China, concentrating on the treatment of ER-positive unresectable or metastatic breast cancer, along with other advanced solid tumors. These trials are designed to assess the safety and efficacy of SHR-A2009, both as a standalone treatment and in conjunction with other anticancer agents.